About Good Manufacturing Practices (GMP)
- GMP is a set of guidelines and quality management principles that ensure pharmaceutical products, as well as other products in the food and healthcare industries, are consistently produced and controlled to meet quality standards appropriate for their intended use.
- GMP covers all aspects of the manufacturing process, including the premises, equipment, personnel, materials, production, quality control, documentation, and storage of finished products.
The Need for Improved Standards
- Alignment with Global Standards: Implementing the new GMP norms will align the Indian pharmaceutical industry with global standards, ensuring that the country’s products meet the expectations of international regulators and consumers.
- Contamination Incidents: Numerous incidents of contamination in India-manufactured syrups, eye-drops, and eye ointments have been reported in other countries, leading to tragic consequences. These incidents have emphasized the need for stricter quality control measures.
- Identified Deficiencies: A risk-based inspection of manufacturing units revealed several deficiencies, such as the lack of testing incoming raw materials, inadequate product quality review, absence of quality failure investigation, infrastructure issues, and the absence of qualified professionals.
Importance of Implementing Revised GMP
- Standardized Processes: The improved standards will ensure that pharmaceutical companies follow standardized processes and quality control measures, thus enhancing the quality of medicines manufactured and sold both in India and globally.
- Recommendations from Chitan Shivir: The implementation of the revised GMP was one of the suggested measures during a Chitan Shivir following the contamination incidents. The stakeholders also recommended the creation of a country-wide IT platform to promote uniformity in licensing and inspection processes across states.
Benefits of the Revised GMP Implementation
- Boosting Regulatory Confidence: Uniform quality standards across the industry will instill confidence in regulators from other countries, potentially reducing the need for repeated inspections.
- Improving Domestic Market Quality: The implementation of revised GMP will enhance the quality of medicines supplied within India, benefitting consumers and public health.
Major Changes in the Revised GMP Guidelines
- Pharmaceutical Quality System: The new guidelines introduce a pharmaceutical quality system to ensure consistent product quality and a thorough investigation of deviations or defects.
- Quality Risk Management: Companies will be required to conduct risk assessments and implement preventive actions to manage quality risks effectively.
- Product Quality Review: Regular quality reviews of all products will be mandated to verify the consistency of quality and processes.
- Validation of Equipment: Pharmaceutical companies will have to validate equipment to ensure the accuracy and reliability of production processes.
- GMP-related Computerized Systems: The guidelines emphasize the use of computerized systems for GMP-related processes to prevent data tampering and unauthorized access.
- Additional Product Requirements: The new schedule M lists requirements for biological products, agents with radioactive ingredients, plant-derived products, and investigational products for clinical trials.
- Urgent Implementation: Pharmaceutical companies must immediately initiate the implementation of the revised Good Manufacturing Practices (GMP) guidelines. Larger companies have six months, and smaller companies have a year to comply.
- Investment in Upgradation: Prioritize investments in facility upgradation, modern equipment, and IT systems to meet the new GMP standards.
- Employee Training and Awareness: Conduct extensive training programs for all employees to educate them about the revised GMP guidelines and their importance.
- Quality Control Enhancement: Strengthen quality control processes and invest in advanced testing equipment and laboratories to ensure product integrity and safety.
- Effective Documentation Systems: Implement robust documentation systems to maintain comprehensive records of manufacturing processes, quality checks, and deviations.
- Continuous Monitoring and Auditing: Regularly monitor manufacturing processes and conduct internal audits to assess GMP compliance.
- The Indian government’s initiative to implement the revised GMP is a commendable step towards bringing the country’s pharmaceutical industry up to global standards. The successful implementation of these improved standards will undoubtedly elevate India’s status in the global pharmaceutical arena